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Celltrion’s YUFLYMA Approved as Interchangeable Biosimilar to Humira

Interchangeable designation of YUFLYMA is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has designated Celltrion Inc.’s YUFLYMA (adalimumab-aaty), as an interchangeable biosimilar to Humira (adalimumab). YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira biosimilar, approved for multiple inflammatory indications. “With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need,” said Thomas Nusbickel, CCO at Celltrio...

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